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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VIVEVE, INC. GENEVEVE ELECTROSURGICAL CUTTING AND COAGULATION DEVICE

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VIVEVE, INC. GENEVEVE ELECTROSURGICAL CUTTING AND COAGULATION DEVICE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Burning Sensation (2146); Numbness (2415)
Event Date 03/23/2017
Event Type  Injury  
Event Description

I received the geneveve treatment which is a rf device vaginal rejuvenation treatment made by viveve, inc. Within a few days of the treatment, my vagina felt numb and still does. It also has a constant burning sensation near the internal area right past my introitus. It's been 16 months and i no longer enjoy vaginal intercourse because of the numb sensation and constant burning feeling. They promote it for vaginal rejuvenation, laxity, dryness and desire.

 
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Brand NameGENEVEVE
Type of DeviceELECTROSURGICAL CUTTING AND COAGULATION DEVICE
Manufacturer (Section D)
VIVEVE, INC.
MDR Report Key7742801
MDR Text Key115956233
Report NumberMW5078794
Device Sequence Number1
Product Code GEI
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 07/30/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/01/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 08/01/2018 Patient Sequence Number: 1
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